As you are aware the EU Clinical Trials Directive has become part of the
UK's regulatory and legal landscape from 1 May, 2004. Richmond
Pharmacology has welcomed the directive which will help to harmonise
trial standards across the board.
We support the MHRA (Medicines and Healthcare products Regulatory
Agency) which regulates implementation of the Directive, and we applaud
our industry partners who have ensured that the implementation does not
slow down or hinder the competitiveness of the UK's clinical research
industry.
This guide has been put
together following numerous client requests for more information and
greater clarity on how the directive will impact on research projects,
timelines and approval systems.